Withholding postoperative antibiotics in pediatric circumcision: A randomized non-inferiority trial in a tropical...

Area of Science:

• Pediatric Surgery
• Infectious Disease Prevention
• Clinical Trials

Background:

• Routine antibiotic use in pediatric circumcision lacks strong evidence for elective procedures.
• This study addresses the common practice of antibiotic prescription in clean elective circumcisions.
• Investigates the efficacy of withholding antibiotics versus standard administration.

Purpose of the Study:

• To determine if withholding routine antibiotics is non-inferior to standard postoperative administration for preventing surgical site infections (SSIs).
• To evaluate the safety and efficacy of an antibiotic-sparing strategy in pediatric circumcision.
• To support antimicrobial stewardship principles in pediatric surgical care.

Main Methods:

• A single-center, randomized, non-inferiority trial involving healthy boys aged 5-15 years undergoing elective circumcision.
• Participants were randomized to receive either standard postoperative oral antibiotics or no antibiotics.
• The primary outcome was SSI within 21 days, with non-inferiority defined by a specific confidence interval for the risk difference.

Main Results:

• 155 patients completed the per-protocol analysis (80 antibiotics, 75 no antibiotics).
• Surgical site infections (SSIs) occurred in 1.3% of patients in both the antibiotic and no-antibiotic groups.
• The risk difference of 0.0% met the non-inferiority criterion, with no serious adverse events reported.

Conclusions:

• Withholding routine antibiotics in healthy children undergoing elective circumcision is non-inferior to standard postoperative use regarding infection risk.
• This approach supports antibiotic-sparing strategies and aligns with antimicrobial stewardship.
• The findings suggest a potential reduction in unnecessary antibiotic exposure in pediatric circumcision.